Push-Pull Controlled Drug Release Systems: Effect of Molecular Weight of Polyethylene Oxide on Drug Release

Nakajima, Taro; Takeuchi, Issei; Ohshima, Hiroyuki; Terada, Hiroshi; Makino, Kimiko

doi:10.1016/j.xphs.2018.02.022

Cited by 10 publications

(5 citation statements)

References 17 publications

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“…Sodium chloride was used as an osmogen, and it has been reported that even when used in smaller concentrations it produces high osmotic pressure, than any other osmogens (Liu et al, 2020;Nie et al, 2020). Nakajima et al, in 2018 studied the effect of different molecular weights of polyethylene oxide and variable orifice diameter on the dissolution profile of a drug from an elementary osmotic pump and reported a sigmoidal release profile with a reduction in orifice diameter (Nakajima et al, 2018). Gundu et al, in 2022 designed push-pull osmotic tablets of Ondensetrone, using five factors-two level full factorial design and studied the effect of different polymers and orifice diameters on drug release till 24 h (Gundu et al, 2020).…”

Section: Design Of Experiments (Doe) For Elementary Osmotic Tabletsmentioning

confidence: 99%

SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™

Saleem

Shoaib²,

Yousuf³

et al. 2022

Front. Pharmacol.

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The study is based on using SeDeM expert system in developing controlled-release tramadol HCl osmotic tablets and its in-silico physiologically based pharmacokinetic (PBPK) modeling for in-vivo pharmacokinetic evaluation. A Quality by Design (QbD) based approach in developing SeDEM-driven full factorial osmotic drug delivery was applied. A 24 Full-factorial design was used to make the trial formulations of tramadol HCl osmotic tablets using NaCl as osmogen, Methocel K4M as rate controlling polymer, and avicel pH 101 as diluent. The preformulation characteristics of formulations (F1-F16) were determined by applying SeDeM Expert Tool. The formulation was optimized followed by in-vivo predictive pharmacokinetic assessment using PBPK “ACAT” model of GastroPlus™. The FTIR results showed no interaction among the ingredients. The index of good compressibility (ICG) values of all trial formulation blends were ≥5, suggesting direct compression is the best-suited method. Formulation F3 and F4 were optimized based on drug release at 2, 10, and 16 h with a zero-order kinetic release (r2 = 0.992 and 0.994). The SEM images confirmed micropores formation on the surface of the osmotic tablet after complete drug release. F3 and F4 were also stable (shelf life 29.41 and 23.46 months). The in vivo simulation of the pharmacokinetics of the PBPK in-silico model revealed excellent relative bioavailability of F3 and F4 with reference to tramadol HCl 50 mg IR formulations. The SeDeM expert tool was best utilized to evaluate the compression characteristics of selected formulation excipients and their blends for direct compression method in designing once-daily osmotically controlled-release tramadol HCl tablets. The in-silico GastroPlus™ PBPK modeling provided a thorough pharmacokinetic assessment of the optimized formulation as an alternative to tramadol HCl in vivo studies.

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Section: Design Of Experiments (Doe) For Elementary Osmotic Tabletsmentioning

confidence: 99%

SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™

Saleem

Shoaib²,

Yousuf³

et al. 2022

Front. Pharmacol.

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“…There are several sigmoidal functions available, the function that is chosen in this study is the original Sigmoidal three parameters function. Some researchers studied drug release reported that they have sigmoidal shape release data, but only a few researchers mention about fitting experimental data using a sigmoidal model [24][25][26][27][28][29]. The most common drug release model used to describe a sigmoidal curve is the Weibull model.…”

Section: Drug Releasementioning

confidence: 99%

The effect of surfactants modification on nanocrystalline cellulose for paclitaxel loading and release study

Putro

Ismadji

Gunarto

et al. 2019

Journal of Molecular Liquids

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“…Hence, it is important to consider the intrinsic solubility of a drug to design alternative formulations and include auxiliary excipients that allow modulating drug release 4 . Such alternatives might include co-compression of the drug with other excipients, coating of drug core with asymmetric membranes, use of swellable polymers, cyclodextrins nanosponges, nanoparticles or use of superdisintegrants (SD) 5,6,7 .…”

Section: Fig 1: Osmotic Push-pull Systemmentioning

confidence: 99%

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2019

IJPSR

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Push-pull osmotic pumps are controlled drug delivery systems for drugs with a broad range of solubilities; especially drugs that are poorly water-soluble. The aim of the present study was to evaluate the performance of the superdisintegrants (SD), crospovidone (CPVP), croscarmellose sodium (CS), and sodium starch glycolate (SSG), in pushpull tablets containing Nifedipine (NP) as a model drug. We performed an in-vitro dissolution test with phosphate buffer (0.05M) at pH 7.5 for 12 h. The amount of released NP was determined using a UV/Visible spectro-photometric method at a wavelength of 238 nm. At 12 h of release, the profile of CPVP-and CS-containing osmotic tablets was like that of the reference product Adalat OROS ® , whereas the SSG-containing tablet showed differences. It is very important mention that in the first 6 h of the assay, all release profiles were different compared to the commercially available reference product. The tablets containing superdisintegrants showed faster drug delivery rates and a reduction in lag time.

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Push-Pull Controlled Drug Release Systems: Effect of Molecular Weight of Polyethylene Oxide on Drug Release

Cited by 10 publications

References 17 publications

SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™

SeDeM tool-driven full factorial design for osmotic drug delivery of tramadol HCl: Formulation development, physicochemical evaluation, and in-silico PBPK modeling for predictive pharmacokinetic evaluation using GastroPlus™

The effect of surfactants modification on nanocrystalline cellulose for paclitaxel loading and release study

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